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    NDC 00597-0164-07 Glyxambi 25; 5 mg/1; mg/1 Details

    Glyxambi 25; 5 mg/1; mg/1

    Glyxambi is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is EMPAGLIFLOZIN; LINAGLIPTIN.

    Product Information

    NDC 00597-0164
    Product ID 0597-0164_c00ed17d-86f6-4d4d-a26a-0cf2e7315a85
    Associated GPIs 27996502300330
    GCN Sequence Number 073433
    GCN Sequence Number Description empagliflozin/linagliptin TABLET 25 MG-5 MG ORAL
    HIC3 C4W
    HIC3 Description ANTIHYPERGLYCEMIC, SGLT-2 AND DPP-4 INHIBITOR COMB
    GCN 37833
    HICL Sequence Number 041724
    HICL Sequence Number Description EMPAGLIFLOZIN/LINAGLIPTIN
    Brand/Generic Brand
    Proprietary Name Glyxambi
    Proprietary Name Suffix n/a
    Non-Proprietary Name empagliflozin and linagliptin
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 25; 5
    Active Ingredient Units mg/1; mg/1
    Substance Name EMPAGLIFLOZIN; LINAGLIPTIN
    Labeler Name Boehringer Ingelheim Pharmaceuticals, Inc.
    Pharmaceutical Class Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA206073
    Listing Certified Through 2024-12-31

    Package

    NDC 00597-0164-07 (00597016407)

    NDC Package Code 0597-0164-07
    Billing NDC 00597016407
    Package 1 BOTTLE in 1 CARTON (0597-0164-07) / 7 TABLET, FILM COATED in 1 BOTTLE
    Marketing Start Date 2015-01-30
    NDC Exclude Flag N
    Pricing Information N/A